Vitamin A And D (Lanolin, Petrolatum) Ointment [Trifecta Pharmaceuticals Usa Llc] -

VITAMIN A AND D (LANOLIN, PETROLATUM) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]
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NDC	69396-009-20
Set ID	453dffec-de9d-0eac-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Trifecta Pharmaceuticals USA LLC
Generic Name
Product Class
Product Number
Application Number	PART347

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Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%
Purpose

Skin Protectant
Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness
Stop use and ask a doctor

Condition worsens

Symptoms last more than 7 days or clear up and occur again with a few days
Keep our of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately
Directions

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Inactive Ingredients

Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin
SPL UNCLASSIFIED SECTION

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

Product of PRC

www.trifecta-pharma.com
Warnings

For external use only

When using this product avoid contact with eyes
STORAGE AND HANDLING

Store at controlled room temperature 20º 25ºC (68º-77ºF)

Questions 1-888-296-9067
Packaging

INGREDIENTS AND APPEARANCE

VITAMIN A AND D
lanolin, petrolatum ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
COD LIVER OIL (UNII: BBL281NWFG)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69396-009-20	1 in 1 BOX	01/03/2017
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/03/2017

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

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Medic